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Janssen Plans New U.S. Filing For Xarelto Based On Positive EINSTEIN-PE Results

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In study of almost 5,000 patients, Janssen/Bayer’s novel anticoagulant proves non-inferior on efficacy compared to old standard of care, with significantly less major bleeding. A mostly one-drug, oral approach could help differentiate the drug from rivals in venous thromboembolism prevention.

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